SIST EN ISO 11810:2003

Optics and optical instruments - Lasers and laser-related equipment - Test method for the laser-resistance of surgical drapes and/or patient-protective covers (ISO 11810:2002)

This Standard applies to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient protective covers which claim to be laser-resistant. It provides a method for testing and classifying surgical drapes and other patient protective covers with respect to laser-induced hazards.

Optik und optische Instrumente - Laser und Laseranlagen - Prüfverfahren zur Laserresistenz von Operationstüchern und/oder andere Abdeckungen zum Schutz des Patienten (ISO 11810:2002)

Diese Internationale Norm legt ein genormtes Verfahren zur Prüfung von Operationstüchern und anderen Abdeckungen zum Schutz des Patienten sowie deren Einteilung in Klassen in Bezug auf laserinduzierte Gefahren fest. Sie gilt für Einwegprodukte und wieder verwendbare gewebte Materialien und Vliesstoffe, die als Operations-tücher und als andere Abdeckungen zum Schutz des Patienten verwendet werden, für die Laserstrahlungs-beständigkeit beansprucht wird. Ein geeignetes Klassifizierungssystem wird angegeben.
Der Zweck dieser Norm besteht nicht darin, als allgemeine Brandsicherheitsvorschrift zu dienen und insofern werden andere Zündquellen von dieser Norm nicht erfasst. Weiterhin wird die Problematik der laserinduzierten Sekundärentzündung nicht berücksichtigt.
Alle Materialien reflektieren Anteile des Strahles und es ist notwendig für den Anwender entscheiden zu können, ob spiegelnde Reflexion eine Gefahr darstellt. Dazugehörige Messungen werden von dieser Norm nicht abgedeckt.

Optique et instruments d'optique - Lasers et équipements associés aux lasers - Méthode d'essai de la résistance au laser des draps chirurgicaux et/ou des couvertures de protection des patients (ISO 11810:2002)

Optika in optični instrumenti - Laserji in z laserji povezana oprema - Preskusna metoda za ugotavljanje odpornosti proti laserju za kirurške zastirke in/ali za varovalna pokrivala za paciente

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2003
• Withdrawal Date: 31-May-2005
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.99 - Other protective equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jun-2005
• Due Date: 01-Jun-2005
• Completion Date: 01-Jun-2005
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11810:2002 - Optics and optical instruments - Lasers and laser-related equipment - Test method for the laser-resistance of surgical drapes and/or patient-protective covers (ISO 11810:2002)

Relations

• Replaced By: SIST EN ISO 11810-1:2005 - Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
• Effective Date: 01-Jun-2005

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11810:2003
01-marec-2003
2SWLNDLQRSWLþQLLQVWUXPHQWL/DVHUMLLQ]ODVHUMLSRYH]DQDRSUHPD3UHVNXVQD
PHWRGD]DXJRWDYOMDQMHRGSRUQRVWLSURWLODVHUMX]DNLUXUãNH]DVWLUNHLQDOL]D
YDURYDOQDSRNULYDOD]DSDFLHQWH
Optics and optical instruments - Lasers and laser-related equipment - Test method for
the laser-resistance of surgical drapes and/or patient-protective covers (ISO 11810:2002)
Optik und optische Instrumente - Laser und Laseranlagen - Prüfverfahren zur
Laserresistenz von Operationstüchern und/oder andere Abdeckungen zum Schutz des
Patienten (ISO 11810:2002)
Optique et instruments d'optique - Lasers et équipements associés aux lasers - Méthode
d'essai de la résistance au laser des draps chirurgicaux et/ou des couvertures de
protection des patients (ISO 11810:2002)
Ta slovenski standard je istoveten z: EN ISO 11810:2002
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.99 Druga varovalna oprema Other protective equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
SIST EN ISO 11810:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11810:2003

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SIST EN ISO 11810:2003
EUROPEAN STANDARD
EN ISO 11810
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2002
ICS 11.140; 13.340.99; 31.260
English version
Optics and optical instruments - Lasers and laser-related
equipment - Test method for the laser-resistance of surgical
drapes and/or patient-protective covers (ISO 11810:2002)
Optique et instruments d'optique - Lasers et équipements Optik und optische Instrumente - Laser und Laseranlagen -
associés aux lasers - Méthode d'essai de la résistance au Prüfverfahren zur Laserresistenz von Operationstüchern
laser des draps chirurgicaux et/ou des couvertures de und/oder andere Abdeckungen zum Schutz des Patienten
protection des patients (ISO 11810:2002) (ISO 11810:2002)
This European Standard was approved by CEN on 19 August 2002.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11810:2002 E
worldwide for CEN national Members.

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SIST EN ISO 11810:2003
EN ISO 11810:2002 (E)
CORRECTED  2002-10-16
Foreword
This document (ISO 11810:2002) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with Technical Committee CEN/TC 123 "Lasers
and laser-related equipment", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by March 2003, and conflicting national
standards shall be withdrawn at the latest by March 2003.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11810:2002 has been approved by CEN as EN ISO 11810:2002 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 11810:2003
EN ISO 11810:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 139 1973 Textiles - Standard EN 20139 1992
atmospheres for conditioning
and testing
ISO 11145 2001 Optics and optical instruments - EN ISO 11145 2001
Lasers and laser-related
equipment - Vocabulary and
symbols
ISO 11146 1999 Laser and laser-related EN ISO 11146 1999
equipment - Test methods for
laser beam parameters - Beam
widths, divergence angle and
beam propagation factor
3

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SIST EN ISO 11810:2003
EN ISO 11810:2002 (E)
Annex ZB
(informative)
Relationship of this document with EC Directives
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association and supports essential requirements of EC Directive(s) :
- EC Directive 93/42/E(E)C
Compliance with this document provides one means of conforming with the specific essential requirements
of the Directive concerned and associated EFTA regulations.
WARNING: Other requirements and other EC Directives may be applicable to the product(s) falling within
the scope of this document.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Table ZB.1— Correspondence between this European Standard and EU Directives
Clause/subclause of this European Corresponding Essential Requirement of
Comments
Standard Directive 93/42/EEC
The whole standard
The test method only
§§ 1; 2; 3; 4; 7.1; 9.2; 9.3; 11.1; 11.3;
12.7.5; 13.1
4

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SIST EN ISO 11810:2003


INTERNATIONAL ISO
STANDARD 11810
First edition
2002-09-15


Optics and optical instruments — Lasers
and laser-related equipment — Test method
for the laser-resistance of surgical drapes
and/or patient-protective covers
Optique et instruments d'optique — Lasers et équipements associés aux
lasers — Méthode d'essai de la résistance au laser des draps chirurgicaux
et/ou des couvertures de protection des patients




Reference number
ISO 11810:2002(E)
©
 ISO 2002

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SIST EN ISO 11810:2003
ISO 11810:2002(E)
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ii © ISO 2002 – All rights reserved

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SIST EN ISO 11810:2003
ISO 11810:2002(E)
Contents Page
Foreword . iv
Introduction. v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Test method. 3
4.1 General conditions. 3
4.2 Testing procedure. 6
5 Classification. 7
5.1 Laser-induced ignition. 7
5.2 Resistance to laser penetration (P) . 8
5.3 Classification prescription. 8
6 Additional requirements. 8
7 Test report. 8
Bibliography. 10


© ISO 2002 – All rights reserved iii

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SIST EN ISO 11810:2003
ISO 11810:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11810 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee
SC 9, Electro-optical systems.

iv © ISO 2002 – All rights reserved

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SIST EN ISO 11810:2003
ISO 11810:2002(E)
Introduction
Only a small number of laser applications in medicine require laser-resistant surgical drapes and/or other
patient-protective covers. Surgical drapes and/or other patient-protective covers are necessary when a sterile
procedure is performed and the surrounding area needs to be protected from liquids, secretions and inadvertent
laser radiation. While conventional surgical drapes and/or other patient-protective covers are not necessarily
laser-resistant, specifically designed drapes offer the possibility of laser-resistance.
Laser-induced risks include ignition, flammability, melting, penetration, thermal transfer and reflectivity. Textile and
non-woven drape materials may have other risks, but they may provide a laser barrier. While there are many
potential ignition devices present in the operating room, e.g. fiberoptic illumination systems, electrosurgical units,
hot wire cauteries, etc., this test method addresses only the laser ignition source. While it may not be necessary for
all materials used in combination with laser equipment to possess laser-resistance, a surgical drape or other
patient-protective cover that claims to be laser-resistant must be tested according to this International Standard.
CO lasers may provide the most challenging conditions of all medical lasers, but this is not certain.
2
Ignition/flammability tests, and penetration tests may disclose more challenging laser wavelengths, as well as
modes of laser delivery, for example Q-switching in the nanosecond range. Nevertheless, the 20 W CO laser
2
(continuous wave) has been selected as the default laser for this International Standard. The structure of this
International Standard is sufficiently general so that it can be performed using other wavelengths, power settings
and modes of delivery. When a CO laser is used in testing under this International Standard, in no case should it
2
have a power level less than 20 W. Users of this test method are cautioned that the laser-resistance of a surgical
drape and/or other patient-protective cover will be wavelength sensitive and that a surgical drape and/or other
patient-protective cover shall be tested at the wavelength for which it is intended. If used, those other wavelengths,
power settings and modes of delivery need to be explicitly stated.

© ISO 2002 – All rights reserved v

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SIST EN ISO 11810:2003

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SIST EN ISO 11810:2003
INTERNATIONAL STANDARD ISO 11810:2002(E)

Optics and optical instruments — Lasers and laser-related
equipment — Test method for the laser-resistance of surgical
drapes and/or patient-protective covers
1 Scope
This International Standard specifies a standardized method for testing and classifying surgical drapes and other
patient-protective covers with respect to laser-induced hazards. It applies to disposable and reusable, as well as
woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be
laser-resistant. An appropriate classification system is given.
It is not the purpose of this International Standard to serve as a general fire safety specification and, as such, it
does not cover other sources of ignition nor does it cover the issue of laser-induced secondary ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance
may be a hazard. This measurement, however, is not covered in this International Standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International
...